Richard Schule, director of clinical education, STERIS Corporation

1. Identify the original equipment manufacturers (OEM) and consult their instructions for use (IFU). According to FDA label requirements, the IFU provides the customer with cleaning and sterilization requirements. Sterile processing and perioperative leadership can then compare requirements with the instrument care products being used in the SPD. As new devices are cleared for market so too are new instrument care products. Assuring that IFU specifications are consistently met helps to lengthen the useful life of expensive, reusable surgical devices.

2. Establish a value analysis and product selection process. Product Value Analysis Committee members typically represent diverse areas of the healthcare facility. The product selection process should be spelled out and documented. Detailed requirements support an efficient process and help to organize data in a systematic format. Should a trial be required, a documented process can identify ownership and help delegate responsibility.

3. Understand the science behind instrument cleaning formulations. Decision-makers should be aware of the factors that contribute to damage and should select formulations that are effective at cleaning surgical soils, including blood, mucous and challenging fatty soils. The formulations should also protect against:

  • The corrosive effects of water.
  • Corrosion from mixed metals.
  • pH effects.
  • Incompatibility with instrument surface substrates.
  • Damage to functional parts such as hinges.
  • Avoidable environmental impact.

4. Promote education and competencies. Work with your product vendors to develop competencies and education programs to orient and maintain the staff’s instrument care knowledge base. You may purchase a great instrument care product, but without proper training and adherence to proper use of the product, you may be damaging your valuable surgical devices due to overexposure or inadequate product performance.

5. Establish quality systems and an audit process. Establishing sound quality systems helps identify reproducible results and assures that you are getting the most from your surgical devices and their care products. The audit process is a key function in a facility’s quality management system (QMS) in which documented education and established competencies can also serve as criteria. Checklists should be developed from the objectives and steps identified in the OEM IFUs. If compliance is an issue, then specific product or performance audits should be performed periodically. If surgical staff mentions instrument staining or poor instrument performance, then more frequent audits may be needed and staff may need re-education on product specifications and proper use.